BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRINEO SKIN CLOSURE SYSTEM

    MDR report key: 3230083 · Received July 16, 2013

    Report

    Report Number
    2210968-2013-13480
    Event Type
    Injury
    Date Received
    July 16, 2013
    Report Date
    July 3, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    OMD
    PMA / PMN Number
    K082289
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A DIEP PROCEDURE ON AN UNKNOWN DATE AND A SURGICAL SEALANT WAS USED. WHEN THE TAPE WAS REMOVED, THE PATIENT DEVELOPED ERYTHEMA AND EDEMA ON THE RIGHT SIDE OF THE INCISION. THE PATIENT WAS TREATED WITH TRIMOVATE AND EUMOVATE CREAM. THE REACTION DID SUBSIDE WITHIN SEVERAL WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328400 PRINEO SKIN CLOSURE SYSTEM SURGICAL SEALANT OMD ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention